X-RepairSL Z021-80SL

GUDID B05502180

Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

Primary Device ID	B05502180
NIH Device Record Key	65e9f552-8a0d-4a46-8a12-21d09a05bc81
Commercial Distribution Status	In Commercial Distribution
Brand Name	X-RepairSL
Version Model Number	Z021-80SL
Catalog Number	Z021-80SL
Company DUNS	140697280
Company Name	SYNTHASOME, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	B05502180 [Primary]

OWW	Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

Steralize Prior To Use	false
Device Is Sterile	true

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B055021160SL	X-RepairSL, Bioabsorbable surgical mesh, single-layer 6mm x 160mm (WxL)
B055020160SL	X‐RepairSL, Bioabsorbable surgical mesh, single‐layer 4mm x 160mm (WxL)
B05502180	X-RepairSL, Bioabsorbable surgical mesh, single-layer 6mm x 80mm (WxL)
B05502120	X-RepairSL, Bioabsorbable surgical mesh, single-layer 6mm x 20mm (WxL)
B05502080	X-RepairSL, Bioabsorbable surgical mesh, single-layer 4mm x 80mm (WxL)
B05502020	X-RepairSL, Bioabsorbable surgical mesh, single-layer 4mm x 20mm (WxL)